FDA: Novo Nordisk insulin may pose heart risk

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Published: Nov 6, 2012 9:44 a.m. ET

Last Updated: Nov 6, 2012 10:39 a.m. ET

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The Food and Drug Administration said it was concerned a proposed, long-acting insulin product being developed by Novo Nordisk A/S (NVO, NOVO-B.KO) might increase the risks of cardiovascular events like heart attacks and strokes.

The FDA released a review of the product Tuesday in advance of an advisory committee meeting on Thursday. Insulins are used to treat diabetes.

Novo Nordisk is seeking FDA approval for its long-acting insulin degludec, which has a proposed brand name of IDeg. The company is also seeking agency approval for use of the product in combination with its short-acting insulin.

The FDA noted that clinical studies, which involved almost 9,000 patients, were not designed to look at heart risks, but said it was concerned about an imbalance of heart-related events seen in studies. The clinical studies were under way before the FDA changed its rules asking companies to design studies to look at cardiovascular risks.

The agency said degludec was effective at lowering a key measure of blood sugar.

The FDA has asked an advisory panel of non-FDA medical experts to discuss the heart-related risks, and to vote on whether it thinks degludec should be approved for marketing. Novo Nordisk has said it believes the FDA will approve degludec, but will require a long-term cardiovascular outcomes study.

(Updates with impact on stock price and adds additional information from FDA's review.)

The Food and Drug Administration said it was concerned a proposed, long-acting insulin product being developed by Novo Nordisk A/S (NVO, NOVO-B.KO) might increase the risks of cardiovascular events like heart attacks and strokes.

The FDA released a review of the product Tuesday in advance of an advisory committee meeting on Thursday, sending the company's shares down by more than 6%.

Insulins are used to treat diabetes, a disease that is characterized by the body's inability to either make or properly use insulin.

Novo Nordisk is seeking FDA approval for its long-acting insulin degludec, or IDeg. The company also is seeking agency approval for use of the product in combination with its short-acting insulin. IDeg is seen as a potential threat to Sanofi SA's (SNY, SAN.FR) top-selling insulin, Lantus.

"Review of these two applications has identified a CV safety signal that requires further investigation," FDA said.

The FDA noted that clinical studies, which involved almost 9,000 patients, weren't designed to look at heart risks but said it was concerned about an imbalance of heart-related events. The clinical studies were under way before the FDA changed its rules asking companies to design studies to look at cardiovascular risks.

However, the data were analyzed to see if there was an increase in a combined measure that looked at heart attack, strokes and cardiovascular-related death in the IDeg patient group compared to patients receiving comparator insulins.

FDA said the analysis, conducted by the company, estimated that IDeg could increase the risk of cardiovascular death and nonfatal heart attacks and strokes by 30% more than comparators.

"The uncertainty around the estimate showed that the increase in risk could be as high as 93% or alternatively that degludec products reduced the risk by 12% relative to comparator," the FDA said.

The FDA has asked an advisory panel of non-FDA medical experts to discuss the heart-related risks and to vote on whether it thinks degludec should be approved for marketing. Novo Nordisk has said it believes the FDA will approve degludec but will require a long-term cardiovascular outcomes study.

The agency said degludec was effective at lowering an important measure of blood sugar.

Novo Nordisk, in documents prepared for Thursday's meeting, said the glucose-lowering impact of IDeg is "longer acting and less variable" than currently available long-acting insulin products, with a low risk of having blood sugar fall too low, which can be fatal in rare cases.

People with diabetes have a higher risk of heart and kidney problems compared to the general population. Insulin is required for people with Type 1 diabetes, an autoimmune disease, who can't make insulin. Insulins also are used to treat advanced cases of Type 2 diabetes, the more common form of the disease. Long-acting insulins are meant to provide a background level of insulin while short-acting insulins are taken with meals.

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